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Hyperosmolality and Acute Kidney Injury After Cardiac Surgery

Primary Purpose

Acute Kidney Injury, Osmolality Disturbance, Cardiopulmonary Bypass

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

HighOsmo

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring Cardiopulmonary Bypass, Priming Solution, Plasma Osmolality, Acute Kidney Injury

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient eligible for routine cardiac surgical procedures requiring cardiopulmonary bypass. Exclusion Criteria: Patients requiring acute surgical intervention within 24 h or profound hypothermia during surgery were excluded.

Sites / Locations

Department of Public Health Clinical Medicine Umeå University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

NormOsmo

HighOsmo

Arm Description

This group received a priming solution with normal osmolality.

This group received a priming solution with high osmolality

Outcomes

Primary Outcome Measures

Postoperative Acute Kidney Injury

Defined according to the KDIGO definition

Secondary Outcome Measures

Full Information

NCT ID

NCT05914896

First Posted

June 7, 2023

Last Updated

June 19, 2023

Sponsor

Umeå University

1. Study Identification

Unique Protocol Identification Number

NCT05914896

Brief Title

Hyperosmolality and Acute Kidney Injury After Cardiac Surgery

Official Title

Hyperosmolar Priming Solution for Cardiopulmonary Bypass May Increase the Risk for Postoperative Acute Kidney Injury: Results From Double-blinded Randomised Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

April 24, 2019 (Actual)

Primary Completion Date

June 24, 2020 (Actual)

Study Completion Date

June 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Umeå University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The goal of this randomized controlled trial is to test if a hyperosmolar prime solution used for cardiopulmonary bypass increases the risk for acute postoperative kidney injury.

Detailed Description

Two-hundred cardiac surgical patients were randomised into two groups based on the osmolality level of the prime solution used for cardiopulmonary bypass. The high osmolality group (966 mOsm) received a prime solution containing Ringer-Acetate 1000 ml + Mannitol 400 ml (60 g) + Sodium-Chloride 40 ml (160 mmol) and Heparin 2 ml (10 000 IU), while the reference group with normal osmolality (388 mOsm) received a prime solution containing Ringer-Acetate 1400 ml and Heparin 2 ml (10 000 IU).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury, Osmolality Disturbance, Cardiopulmonary Bypass

Keywords

Cardiopulmonary Bypass, Priming Solution, Plasma Osmolality, Acute Kidney Injury

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomisation into two groups based on the osmolality level in the priming solution used for cardiopulmonary bypass.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Priming of the heart-lung machine performed by a staff member not affiliated to the study protocol.

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NormOsmo

Arm Type

No Intervention

Arm Description

This group received a priming solution with normal osmolality.

Arm Title

HighOsmo

Arm Type

Active Comparator

Arm Description

This group received a priming solution with high osmolality

Intervention Type

Drug

Intervention Name(s)

HighOsmo

Intervention Description

This group received a priming solution with high osmolality

Primary Outcome Measure Information:

Title

Postoperative Acute Kidney Injury

Description

Defined according to the KDIGO definition

Time Frame

Three days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Staffan Svenmarker, PhD

Organizational Affiliation

Public Health & Clinical Medicine Umeå University, Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Public Health Clinical Medicine Umeå University

City

Umeå

State/Province

Vasterbotten

ZIP/Postal Code

SE 901 85

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Limited by ethical regulations

Learn more about this trial

Hyperosmolality and Acute Kidney Injury After Cardiac Surgery

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